Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
Study NCT ID:
NCT03992092
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2019-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Video Stylet vs. Flexible Bronchoscopy for C-Spine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Participants will be blinded, as will Anesthesiologist providing care, but the investigator who performs the intubation will be aware of the intubation technique he used. Similarly, the Radiologist measuring the C-spine movement will be able to see the device on the fluoroscopic images.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel randomised controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2019-06-13', 'studyFirstSubmitQcDate': '2019-06-17', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Intubation', 'timeFrame': 'Concurrent, during the intubation', 'description': 'Duration of Intubation'}], 'secondaryOutcomes': [{'measure': 'C-Spine Movement', 'timeFrame': 'Concurrent, during the intubation', 'description': 'Degrees of C-Spine Movement as measured via Fluoroscope'}, {'measure': 'Sore Throat', 'timeFrame': '24-48 hours post-op.', 'description': 'Sore Throat rated as none, mild, moderate, or Severe'}, {'measure': 'Vocal Changes', 'timeFrame': '24-48 hours post-op.', 'description': 'Vocal Changes rated as none, mild, moderate, or Severe'}, {'measure': 'Ease of Intubation', 'timeFrame': 'Concurrent, during the intubation', 'description': 'Duration of Intubation, scored on a 100 mm VAS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical spine injury'], 'conditions': ['Intubation;Difficult', 'Intubation Complication']}, 'descriptionModule': {'briefSummary': 'Comparison of cervical spine movement during intubation with the C-MAC Video Stylet to Flexible Bronchoscopy', 'detailedDescription': 'Elective surgical patients who require intubation will be randomised to one of 2 groups:\n\n1. C-MAC Video Stylet\n2. Flexible Bronchoscopy During intubation, fluoroscopy will be recorded for later analysis to determine the amount of cervical spine movement during the intubation process.\n\nThe intubation will also be timed to determine the duration of the intubation process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective Surgery requiring oral intubation\n* undergoing elective non-cardiac surgery\n* American Society of Anesthesiologists physical status 1-3\n* age 18-80 years\n\nExclusion Criteria:\n\n* gastro-esophageal reflux disease\n* body mass index \\> 35 kg/m2\n* possibility of pregnancy\n* previous neck surgery\n* unstable C-spine\n* known or predicted difficult airway.'}, 'identificationModule': {'nctId': 'NCT03992092', 'briefTitle': 'Video Stylet vs. Flexible Bronchoscopy for C-Spine', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Comparison of Video Stylet to Flexible Bronchoscopy for Intubation of Patients With Potential Cervical Spine Injury', 'orgStudyIdInfo': {'id': 'ReDa 7685'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C-Mac VS', 'description': 'Intubation using the C-MAC Video Stylet', 'interventionNames': ['Device: C-MAC VS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FB', 'description': 'Intubation using the Flexible Bronchoscope', 'interventionNames': ['Device: Flexible Bronchoscopy']}], 'interventions': [{'name': 'C-MAC VS', 'type': 'DEVICE', 'description': 'C-MAC Video Stylet', 'armGroupLabels': ['C-Mac VS']}, {'name': 'Flexible Bronchoscopy', 'type': 'DEVICE', 'description': 'Flexible Bronchoscopy', 'armGroupLabels': ['FB']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A5A5', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'T Turkstra', 'role': 'CONTACT', 'phone': '5196858500', 'phoneExt': '35677'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'centralContacts': [{'name': 'Timothy Turkstra, MD', 'role': 'CONTACT', 'email': 'timothy.turkstra@lhsc.on.ca', 'phone': '5196858500', 'phoneExt': '35677'}], 'overallOfficials': [{'name': 'Timothy Turkstra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LHSC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor and Staff Anesthesiologist', 'investigatorFullName': 'Timothy Turkstra', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}